Product Licensing Guidance Document, Version 2. It has not been altered or updated after the date of archiving. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. Fundamentals of Nursing Exam 13: NLE Pre-Boards (100 Items) By. Matt Vera, RN - Jan 26, 2014. Facebook; Introduction. Pre-board examinations are mock exams that simulate the licensure examinations in the. Keep rubbing while rotating fingers through each other up to. Make sure site for new patch is clean. PHARM OBJECTIVES EXAMS 3- 8. You are to apply a transdermal patch of nitoglycerin to your client. After cleaning the abrasions and applying antiseptic. As per the Communications Policy of the Government of Canada, you can request alternate formats on the . H1. 64- 3. 6/2. 00. EISBN 0- 6. 62- 4. Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and Power. Point (PPT) files, can be obtained in the alternate format help section. Table of Contents.
Applying heat to the injection site. A patient with motion sickness is planning a cross-country car trip and has a new prescription for a scopolamine transdermal patch. Exelon Patch is for transdermal use on intact skin. Change the site of patch application daily to minimize potential. Avoid applying Exelon Patch to areas on your body that will be rubbed against tight. Start studying Foundations Chapter 32 Medication Administration. Learn vocabularly, terms, and more with flashcards, games, and other study tools. Overview. All natural health products (NHPs) marketed for sale in Canada are subject to the Food and Drugs Act. The regulatory requirements specific to NHPs are outlined in the Natural Health Products Regulations (the Regulations). This guidance document is intended to help product licence applicants interpret the terminology used in Section 5 of the Regulations and to complete a product licence application form and animal tissue form (if applicable). Included in this guidance document are a description of the different submission types and their specific requirements. The product licence application form and all other relevant forms may be found on the Internet. The product licence application form (along with the label text and supporting safety, efficacy and quality information, when required) may be used to apply for a new product number (NPN or DIN- HM in the case of homeopathic medicines) from the Natural Health Products Directorate (NHPD) as part of the product licence or it may also be used to apply for an amendment or provide a notification of changes for products that are already licensed. Sections of the Regulations text appear in boxes in relevant locations throughout this guidance document. A complete version of the Regulations is available. The information in this guidance document is based on the Natural Health Products Regulations, which were published in Canada Gazette, Part II, on June 1. The Regulations came into force on January 1, 2. Applications for Product Licences. The Natural Health Products Regulations (the Regulations) require individuals to obtain a product licence before they can sell a natural health product (NHP) in Canada. The application must include sufficient data to allow NHPD to evaluate the safety, quality and efficacy of the NHP when used according to the recommended conditions of use. The only difference between these products must be the list of non- medicinal ingredients; all other information (e. For example, a product that is sold in bottles containing 9. Table 2. 0: Product Application Requirements. Requirements. Application Type. Compendial(NHPD Monograph)Traditional Claim. Non- traditional Claim. Homeopathic. TPD Category IV/Labelling Standard. Homeopathic DINTransitional DINRegular stream. Pharmacopoeial stream. Specific Recommended use. Non- specific Recommended Use. Product Licence Application form. XXXXXXXXXNHPD Label text. XXXXXXXX AX AEvidence Summary Report. Not applicable. XNot applicable. XNot applicable. Not applicable. Not Applicable. Not Applicable. Not applicable. References. BCHDE, FFGNot applicable. Not applicable. Safety Summary Report. Not applicable. XXXNot applicable. Not applicable. Not applicable. Not applicable. Not applicable. Animal Tissue form(if applicable)XXXXXXXXXQuality Summary Report (including finished product specifications)Not applicable. XXXXXXXX2. 1 Compendial Applications. Section 6 of the Regulations outlines the time limitation for a compendial product licence application. Part 1: Product Licences. Sixty- Day Disposition. Section 6. 6. The monographs provide information regarding the minimum quality requirements, the acceptable non- medicinal ingredients as well as support for the safety and the efficacy of the NHP. Several items on the product licence application need to parallel the monograph content exactly, including: medicinal ingredient proper name; medicinal ingredient common name; source of the medicinal ingredient; route of administration; dose; duration of use for the product (if any); andsubpopulation group. The remaining sections of the monograph may use a . Note that the Compendium of Monographs also contains quality information. If any other information submitted is not identical to that on the monograph (e. Products that contain ingredients that are combined and not allowed within one monograph will not be considered as compendial and thus not subject to the 6. The Compendium of Monographs outlines the requirements for review within the 6. For further information, refer to the Compendium of Monographs. For a list of NHPD Single Ingredient Monographs, see the list of published Single Ingredient Monographs, and for a list of NHPD Product Monographs, see the list of published Product Monographs. The submission requirements for a compendial application can be found in Table 2. For an example of a completed product licence application form refer to Appendix 1 of this guidance document. Traditional Claim Applications. The NHPD considers a traditional claim to encompass products that have been used within a cultural belief system or healing paradigm for at least 5. To make a traditional use claim, the method of preparation should be considered to be traditional and a minimum of two traditional references should be submitted supporting the recommended conditions of use or one acceptable Pharmacopoeial reference (e. Pharmacopoeia of the People's Republic of China, or State Drug Standard). When the application is for a combination product (i. Refer to the Evidence for Safety and Efficacy of Finished Natural Health Products guidance document for additional information on the safety and evidence requirements for products with a traditional claim. For an example of a completed product licence application form refer to Appendix 2 of this guidance document. Non- Traditional Claim Applications. For products for which applicants wish to make a non- traditional claim, scientific evidence supporting the safety and efficacy of the product according to the recommended conditions of use must be submitted. In cases of combination products that contain medicinal ingredients that have NHPD Monographs, applicants may cite the relevant NHPD monograph to support the safety and efficacy of that particular medicinal ingredient. For example, a product containing two medicinal ingredients with both ingredients having a NHPD monograph (i. If a product does not meet the requirements of a NHPD monograph, Therapeutic Product Directorate (TPD) Category IV Monograph (TPD CAT IV) and a TPD Labelling Standard (LS), it can be submitted as an application as a non- traditional product. For example, a product containing only one medicinal ingredient that has a monograph (i. However, as part of the Safety and Evidence Summary Report, a Combination Rationale should be provided if applicable. More information regarding the Safety and Evidence Summary Report and the requirements for a Combination Rationale can be found in the Evidence for Safety and Efficacy of Finished Natural Health Products guidance document. For an example of a completed product licence application form refer to Appendix 3 of this guidance document. Homeopathic Applications. To be considered a Homeopathic Medicine, a product must meet two criteria. It should be: Manufactured from, or contain as medicinal ingredients, only those substances referenced in a homeopathic monograph in one of the following homeopathic pharmacopoeias, as they are amended from time to time: Homeopathic Pharmacopeia of the. United States (HPUS)Hom. The submission requirements for a specific and non- specific recommended use or purpose for a homeopathic application can be found in Table 2. The evidence package for a specific recommended use or purpose should include: for each medicinal ingredient, a photocopy of the monograph from the pharmacopoeia to which the applicant attests; andfor homeopathic medicines with a specific use or purpose, photocopied and underlined evidence from at least one homeopathic reference to support the recommended use or purpose of each medicinal ingredient. The evidence package for a non- specific recommended use or purpose should include: a photocopy of the monograph from the pharmacopoeia to which the applicant attests for each medicinal ingredient. For further information on homeopathic medicines and for an example of a completed product licence application form for a homeopathic medicine refer to the Evidence for Homeopathic Medicines guidance document. TPD Category IV/Labelling Standard Applications. Therapeutic Products Directorate (TPD) Category IV Monographs and Labelling Standards were originally prepared by the TPD in the 1. DINs (Drug Identification Numbers) for low risk non- prescription drug products. TPD Labelling Standards were developed for drug products that had been on the market for a number of years and for which there was no need for companies to generate further evidence to support the safety and efficacy of the product. Upon the introduction of the Natural Health Product Regulations, the ingredients outlined in the TPD Category IV Monographs and Labelling Standards were reviewed and some substances were reclassified as NHPs rather than drugs. Thus, products with a single or a combination of NHP ingredients are now governed by the Natural Health Product Regulations rather than the Food and Drug Regulations. Products containing both an NHP and a drug ingredient will be considered to be drugs, and will continue to be regulated by the TPD under the Food and Drug Regulations. The NHPD is currently adapting the relevant TPD Category IV Monographs and Labelling Standards information into NHPD monographs. Once these monographs are incorporated into the NHPD Compendium of Monographs, all requirements for a Compendial submission will apply (refer to chapter 2. Exelon Patch - FDA prescribing information, side effects and uses Alzheimer’s Disease. Exelon Patch is indicated for the treatment of dementia of the Alzheimer’s type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease. For mild to moderate AD and PDD patients, continue the effective dose of 9. Patients can then be increased to the maximum effective dose of 1. For patients with severe AD, 1. Doses higher than 1. If dosing is interrupted for more than 3 days, restart treatment with the 4. Exelon Patch and titrate as described above. If sites on the back are not accessible, apply the patch to the upper arm or chest. Do not apply to a skin area where cream, lotion, or powder has recently been applied.(c) Do not apply to skin that is red, irritated, or cut.(d) Replace the Exelon Patch with a new patch every 2. Instruct patients to only wear 1 patch at a time (remove the previous day’s patch before applying a new patch) . If a patch falls off or if a dose is missed, apply a new patch immediately and then replace this patch the following day at the usual application time.(e) Change the site of patch application daily to minimize potential irritation, although a new patch can be applied to the same general anatomic site (e. Do not apply a new patch to the same location for at least 1. May wear the patch during bathing and in hot weather. But avoid long exposure to external heat sources (excessive sunlight, saunas, solariums).(g) Place used patches in the previously saved pouch and discard in the trash, away from pets or children. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve. Each patch has a beige backing layer labeled as either: EXELON. The majority of medication errors have involved not removing the old patch when putting on a new one and the use of multiple patches at one time. Dehydration may result from prolonged vomiting or diarrhea and can be associated with serious outcomes. The incidence and severity of these reactions are dose- related . For this reason, initiate treatment with Exelon Patch at a dose of 4. A postmarketing report described a case of severe vomiting with esophageal rupture following inappropriate reinitiation of treatment of an oral formulation of rivastigmine without retitration after 8 weeks of treatment interruption. Inform caregivers to monitor for gastrointestinal adverse reactions and to inform the physician if they occur. However, use of rivastigmine patch may lead to allergic contact dermatitis. Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e. In these cases, treatment should be discontinued . It is possible that some patients sensitized to rivastigmine by exposure to rivastigmine patch may not be able to take rivastigmine in any form. In these cases, treatment should be discontinued . Patients and caregivers should be instructed accordingly. Worsening of parkinsonian symptoms, particularly tremor, has been observed in patients with dementia associated with Parkinson’s disease who were treated with EXELON Capsules. Seizures: Drugs that increase cholinergic activity are believed to have some potential for causing seizures. However, seizure activity also may be a manifestation of Alzheimer's disease. Peptic Ulcers/Gastrointestinal Bleeding. Cholinesterase inhibitors, including rivastigmine, may increase gastric acid secretion due to increased cholinergic activity. Monitor patients using Exelon Patch for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers, e. NSAIDs). Clinical studies of rivastigmine have shown no significant increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Use with Anesthesia. Rivastigmine, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine- type muscle relaxation during anesthesia. Cardiac Conduction Effects. Because rivastigmine increases cholinergic activity, use of the Exelon Patch may have vagotonic effects on heart rate (e. The potential for this action may be particularly important in patients with sick sinus syndrome or other supraventricular cardiac conduction conditions. In clinical trials, rivastigmine was not associated with any increased incidence of cardiovascular adverse events, heart rate or blood pressure changes, or ECG abnormalities. Genitourinary Effects. Although not observed in clinical trials of rivastigmine, drugs that increase cholinergic activity may cause urinary obstruction. Pulmonary Effects. Drugs that increase cholinergic activity, including Exelon Patch should be used with care in patients with a history of asthma or obstructive pulmonary disease. The administration of rivastigmine may also result in adverse reactions that are detrimental to these functions. During treatment with the Exelon Patch, routinely evaluate the patient's ability to continue driving or operating machinery. Of these, 3. 00. 5 patients have been treated for at least 2. Mild to Moderate Alzheimer’s Disease. Week International Placebo- Controlled Trial (Study 1)Most Common Adverse Reactions. The most common adverse reactions in patients administered Exelon Patch in Study 1 . These reactions were dose- related, with each being more common in patients using the unapproved 1. Exelon Patch than in those using the 9. Exelon Patch. Discontinuation Rates. In Study 1, which randomized a total of 1. Exelon Patch 9. 5 mg/2. EXELON Capsules 6 mg twice daily, and placebo groups who discontinued treatment due to adverse events were 1. The most common adverse reactions in the Exelon Patch- treated groups that led to treatment discontinuation in this study were nausea and vomiting. The proportions of patients who discontinued treatment due to nausea were 0. Exelon Patch 9. 5 mg/2. EXELON Capsules 6 mg twice daily, and placebo groups, respectively. The proportions of patients who discontinued treatment due to vomiting were 0%, 2. Exelon Patch 9. 5 mg/2. EXELON Capsules 6 mg twice daily, and placebo groups, respectively. Adverse Reactions Observed at an Incidence of . The unapproved 1. Exelon Patch arm is included to demonstrate the increased rates of gastrointestinal adverse reactions over those seen with the 9. Exelon Patch. Table 1: Proportion of Adverse Reactions Observed with a Frequency of . Body weight was also monitored at prespecified time points throughout the course of the clinical study. The proportion of patients who had weight loss equal to or greater than 7% of their baseline weight was 8% of those treated with Exelon Patch 9. Exelon Patch 1. 7. EXELON Capsule at doses up to 6 mg twice daily and 6% of those who received placebo. It is not clear how much of the weight loss was associated with anorexia, nausea, vomiting, and the diarrhea associated with the drug. Exelon Patch. 9. 5 mg/2. Exelon Patch. 17. EXELON Capsule. 6 mg twice daily. Placebo. Total Patients Studied. Total Percentage of Patients with ARs (%)5. Nausea. 72. 12. 35. Vomiting*6. 19. 17. Diarrhea. 61. 05. Depression. 44. 41. Headache. 34. 62. Anxiety. 33. 21. Anorexia/Decreased Appetite. Weight Decreased**3. Dizziness. 27. 72. Abdominal Pain. 24. Urinary Tract Infection. Asthenia. 23. 61. Fatigue. 22. 11. Insomnia. Abdominal Pain Upper. Vertigo. 02. 11. 48- Week International Active Comparator- Controlled Trial (Study 2)Most Common Adverse Reactions. In Study 2 . The percentage of patients with these events was higher in the Exelon Patch 1. Exelon Patch 9. 5 mg/2. Patients with nausea, vomiting, diarrhea and decreased appetite experienced these reactions more often during the first 4 weeks of the double- blind treatment phase. These reactions decreased over time in each treatment group. Weight decreased was reported to have increased over time in each treatment group. Discontinuation Rates. Table 2 displays the most common adverse reactions leading to discontinuation during the 4. Study 2. Table 2: Proportion of Most Common Adverse Reactions (> 1% at Any Dose) Leading to Discontinuation During 4. Double- Blind Treatment Phase in Study 2. Exelon Patch. 13. Exelon Patch. 9. 5 mg/2. Total. Total Patients Studied. Total Percentage of Patients with ARs Leading to Discontinuation (%)9. Vomiting. 1. 4. 0. Application site pruritus. Aggression. 0. 4. Most Common Adverse Reactions . The percentage of patients with these reactions decreased over time in each treatment group (Table 3). The adverse reaction severity profile was generally similar for both the Exelon Patch 1. Table 3: Proportion of Adverse Reactions Over Time in the 4. Double- Blind (DB) Treatment Phase (at Least 3% in any Treatment Group) in Study 2*Decreased Weight as presented in Table 3 is based upon clinical observations and/or adverse events reported by patients or caregivers. Body weight was monitored as a vital sign at pre- specified time points throughout the course of the clinical study. The proportion of patients who had weight loss equal to or greater than 7% of their baseline weight was 1. Exelon Patch 9. 5 mg/2. Exelon Patch 1. 3. Cumulative Week 0 to 4. DB Phase)Week 0 to 2. DB Phase)Week > 2. DB Phase)Preferred Term. Exelon Patch. 13. Exelon Patch. 9. 5 mg/2. Exelon Patch. 13. Exelon Patch. 9. 5 mg/2. Exelon Patch. 13. Exelon Patch. 9. 5 mg/2. Total Patients Studied. Total Percentage of Patients with ARs (%)7. Nausea. 12. 51. 04. Vomiting. 10. 59. Fall. 86. 44. 43. Weight decreased*7. Application site erythema. Decreased appetite. Diarrhea. 65. 54. Urinary tract infection. Agitation. 55. 43. Depression. 55. 33. Dizziness. 41. 3< 1. Application site pruritus. Headache. 44. 44< 1< 1. Insomnia. 43. 21. Abdominal pain upper. Anxiety. 43. 22. 21. Hypertension. 33. Urinary incontinence. Psychomotor hyperactivity. Aggression. 23. 13. Severe Alzheimer’s Disease. Week US Controlled Trial (Study 3)Most Commonly Observed Adverse Reactions.
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